Kornimate/medical-research-clean huggingface dataset:
use of defibrillator information in the emergency department

Conditions: Congestive Heart Failure; Medical Device

Summary: this is a study to determine the feasibility of obtaining information stored in existing medtronic internal defibrillators in patients who present to the emergency department(ed) for any reason. in addition, the study will determine if this information is useful to the ed physician in managing the patient's care, specifically as it relates to heart failure.

this is a prospective observational pilot study to determine if stored data regarding heart function, patient activity level, and other parameters can be used by the ed physician in order to evaluate a patient's cardiac status as it pertains to heart failure. patients presenting to the ed and who consent have their devices interrogated by research personnel. the data is printed and provided to the treating physician who completes a brief survey about whether the data was useful in managing the patient.all subjects are contacted 30 days after ed or hospital discharge to determine if they have had any ed visits or hospital admissions during that period, and if yes, whether the visits were heart failure related. after all study procedures are performed, a team of 2 cardiologists will review the patient medical record from the study visit, as well as the data obtained from the patient's device in the ed. each cardiologist, who will be blinded to the other's conclusion, will determine if the patient was having a heart failure exacerbation at the study visit.

Eligibility criteria:
inclusion criteria: * age 18 or older * medtronic iacd present on arrival to emergency dept. exclusion criteria: * minors * prisoners * non-medtronic aicd * unable to provide consent * no telephone for 30 day follow up call

Keywords: implanted cardiac defibrillators congestive heart failure emergency department
safety and immunogenicity study of gsk biologicals' pandemic influenza candidate vaccine (h1n1) (gsk2340272a)

Conditions: Influenza

Summary: this trial is designed to assess the safety and immunogenicity of a prime-boost schedule of gsk biologicals' investigational vaccine gsk2340272a in children aged between 3 and 17 years.


Eligibility criteria:
inclusion criteria: * subjects who the investigator believes that their parent(s)/legally acceptable representative(s) (lar) can and will comply with the requirements of the protocol. * children, male or female, aged between 3 and 17 years at the time of the first study vaccination. * written informed consent obtained from the subject parent(s) or lar(s) of the subject. assent obtained from the subject when applicable. * healthy children as established by medical history and clinical examination when entering into the study. * parent/lar with access to a consistent means of telephone contact, land line or mobile, but not a pay phone or other multiple-user. exclusion criteria: * use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period. * clinically or virologically confirmed influenza infection within six months preceding the study start. * planned administration of any vaccine 30 days prior and 30 days after any study vaccine administration. * chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to enrolment in this study or planned administration during the study period. * acute disease and/or fever at the time of enrolment * any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination. * acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination. * previous administration of any h1n1 a/california-like vaccine. * administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned during the study. * if the subject is female and if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for two months after completion of the vaccination series. * any known or suspected allergy to any constituent of influenza vaccines;a history of anaphylactic-type reaction to any constituent of influenza vaccines; or a history of severe adverse reaction to a previous influenza vaccine. * known use of an analgesic or antipyretic medication within 12 hours prior to first vaccination. * child in care.

Keywords: influenza infection gsk bio's influenza vaccine gsk2340272a
connective tissue graft from tuberosity area and l-prf associated with coronally advanced flap for root coverage

Conditions: Gingival Recession

Summary: the aim of the present randomized controlled clinical study is to compare the efficacy of subepithelial connective tissue graft harvested from the maxillary retromolar tubeosity area and l-prf membranes in the treatment of rt1 recessions by coronally advanced flap. a total of 30 patients will be recruited and randomly assigned to the test group treated with caf+tsctg or the control group treated with (caf+l-prf). for each experimental site the parameters of gingival recession (gr), pocket depth (pd), clinical attachment level (cal), keratinized gingiva width (kt) and gingival thickness (gt) will be analyzed at baseline (t0) and at 12 months after the surgical procedure (t1). in addition, was also evaluated the different morbidity of the two surgical techniques, using the vas scale values recorded in the first 2 weeks following surgery. it was checked the patient related esthetic score and dentine hypersensivite reduction.


Eligibility criteria:
inclusion criteria: * presence of a class rt1 recession; * age \> 18 years; * systemic health conditions that do not affect the periodontium; * non smoker; * fmps and fmbs values \< 20% before the surgical procedure; * absence of implants or subgingival restorations in the sites to be treated; * presence of adequate tissue distal to the last maxillary molar.

Keywords: root coverage periodontal plastic surgery
evaluation of the impact of an individual peer support intervention for stroke patients when returning home: a mixed methods pilot study

Conditions: Stroke

Summary: going back home following a stroke is a key step for the patient and his or her relatives. due to the brutality of stroke and increasingly shorter in-hospital lengths of stay, patients and their families must adapt quickly to the patient's new health functioning and the new caregiving and support role for family members. peer support could be an innovative and inexpensive approach to addressing these issues. peer-helpers are patient-partners who put their experiential knowledge from life with the disease at the disposal of other patients to offer them social and emotional support in the management of the disease in connection with care, social and community structures. group peer support programs face organizational challenges and fail to address the full range of patient needs for stroke home visits. individualized and more flexible support could better meet the needs of patients. our hypothesis is that individual peer support improves quality of life and patient empowerment during the discharge period compared to usual practice.


Eligibility criteria:
inclusion criteria: * adult patient, * having had a first confirmed, ischemic or hemorrhagic stroke * managed in the participating rehabilitation center * whose discharge to home directly from the rehabilitation center is planned * presenting a modified rankin score of 1 to 3 when deciding to leave the stroke center * having given its written consent * whose main residence is located in the rhône department * aphasic patients may be included if a caregiver can follow up with the case manager exclusion criteria: * patient living in an institution prior to stroke * included in a gerontological network before stroke * patient unable to understand quality of life questionnaires * patient with unstable medical or psychological conditions who, in the opinion of the investigator, could lead the subject to be non-compliant or uncooperative during the study or could compromise patient safety or participation in the study * patient under guardianship or curatorship * patient not affiliated to a social health insurance

Keywords: stroke peer support
thermrheum version 1

Conditions: Arthritis

Summary: childhood arthritis is a diagnosis made by clinicians based upon their clinical examination, during which patients are assessed for signs of swelling, warmth and restricted movement of the joints using the sensation of touch. clinicians use investigations such as blood tests and scans which may be costly, associated with waiting times, can cause the patient stress or anxiety. patients with childhood arthritis can often present with flares of their condition even when on medical treatment, which may require further investigations to determine the nature of the problem. studies in adult rheumatology have demonstrated that a thermal imaging camera (which detects heat given off by the body) can be useful in assessing for signs of inflammation in arthritis. the use of this camera could provide an alternative to the tests described; it does not require any contact with the patient, is quick and easy to use, and does not emit any radiation. the investigators hope that this pilot study will demonstrate that thermal imaging can be used to complement the standardised assessments of joint inflammation as done routinely in clinic and may lead to further work comparing thermal imaging with other tests such as mri scanning and ultra-sound. the investigators will recruit 20-50 children with arthritis affecting either knee or ankle joints. the investigators will use a highly sensitive thermal imaging camera to take pictures and short video recordings of each ankle and knee joint, recording skin temperature and colour. the investigators will compare this with the clinicians' assessment of whether the knee and ankle joints are inflamed or not. the investigators are interested in finding out whether the information recorded using the camera mirrors the assessment made by the clinician.


Eligibility criteria:
inclusion criteria: diagnosis of: * poly-articular jia * oligo-articular jia * psoriatic jia * enthesitis-related jia exclusion criteria: cyp below 4 years of age (pgals is validated for school-age children and patients will be required to remain still during ti process) ongoing active/chronic infection requiring hospitalisation or treatment with intravenous antibiotics within 30 days of recruitment, or oral antibiotics within 14 days of recruitment history of active tuberculosis of less than 6 months treatment or untreated latent tuberculosis soft tissue infection, injury or fracture of the affected joint which could confound the ti signature presence of any inflammatory skin condition (including, but not limited to eczema and psoriasis) which may be in close proximity to or overlying the joint presence of any other diagnosis which could cause arthritis including systemic-jia (associated systemic inflammation may affect skin temperature independently of arthritis) or undifferentiated-jia (excluded to ensure homogeneity of the sample investigated) non-english speaking patients and/or parent(s)/guardian(s) non-consenting cyp, or parent(s)/guardian(s)
pycnogenol and endothelial function in coronary artery disease

Conditions: Coronary Artery Disease

Summary: pycnogenol® is a proprietary bark extract of the french maritime pine tree (pinus pinaster ssp. atlantica). pycnogenol® has prevented pathologic symptoms such as chronic inflammation and increased platelet aggregation, a risk factor for cardiovascular diseases. the endothelium is increasingly recognized not only a target (with vascular remodelling occurring in response to an injury and resulting in atherosclerosis), but also a mediator in the pathogenesis of atherosclerosis. indeed, endothelial cells play an important regulatory role in the cardiovascular system by the expression of numerous molecules and release of mediators such as nitric oxide (no), superoxide and endothelin-1 (et-1). data from animal studies, as well as human studies indicate that pycnogenol may improve endothelial function, which is a powerful surrogate for clinical prognosis.


Eligibility criteria:
inclusion criteria: * history of coronary artery disease (documented by coronary angiogram, nuclear imaging, positive stress test) * stable cardiovascular medication for at least 1 month * age ≥ 18 years of age at time of signing the informed consent * informed consent for participation in the study exclusion criteria: * myocardial infarction, unstable angina, stroke (within 3 months before randomization) * thoracic or cardiac surgery and/or coronary intervention/revascularisation procedure (within 3 months before randomization) * uncontrolled symptomatic congestive heart failure (nhya\> ii) in the last 4 weeks prior to study * renal insufficiency (creatinine clearance \< 50ml/min) * ventricular tachyarrhythmias * poorly controlled hypertension, defined as resting blood pressure ≥ 160/100 mmhg * symptomatic hypotension * obstructive cardiomyopathy, active myocarditis, constrictive pericarditis, untreated hypothyroidism or hyperthyroidism and adrenal insufficiency * severe uncorrected valvular disease or left ventricular outflow obstruction, which, in the opinion of the investigator, requires surgery * long acting nitrates * oral or intravenous steroids therapy * insulin - dependent diabetes mellitus * recipient of any major organ transplant (eg, lung, liver, heart) or renal replacement therapy * malignancy (unless healed or remission \> 5 years) * anaemia (hb\< 10g/dl) * known to be human immunodeficiency virus (hiv) positive or active virus - hepatitis * alanine transaminase (alt) or aspartate transaminase (ast) \> 3 times the upper limit of the normal range * known hypersensitivity to pycnogenol® * alcohol, nicotine abuse or illicit drug abuse * pregnancy or breast-feeding, women with child - bearing potential without adequate contraception * disease with systemic inflammation (e.g. rheumatoid arthritis, m. crohn) * participation in another study within the last month

Keywords: coronary artery disease endothelial dysfunction nitric oxide
biomarker-driven therapy for melanoma

Conditions: Melanoma

Summary: patients included will undergo biopsy and the molecular analysis will be discussed at the institutional molecular tumor board. the recommandation of the molecular tumor board will be provided to the physician in charge of the patient for final treatment desicion. the main endpoints are the number of patients with actionable molecular alterations, the number of patients with a treatment recommendation, the number of patients receiving the recommended therapy, overall survival of the patients treated according to recommendations or not. for patients treated according to the recommendations: response rate and progression free survival at 6 months according to recist criteria.

eligible patients have to have a histologically proven metastatic melanoma failing standard treatments. other inclusion criteria included age ≥ 18 years; eastern cooperative oncology group (ecog) performance status (ps) 0-2; life expectancy ≥ 24weeks; adequate renal, liver, and bone marrow functions. previous therapy with intravenous chemotherapy, immunotherapy or major surgery at least 4 weeks before inclusion was allowed. patients were excluded if they had a history of cardiac disease or metastatic brain or meningeal tumors. the study is approved by the institutional research ethics board. molecular analysis is performed at the max planck institute for molecular genetics berlin and a comprehensive report is made available with 4-8 weeks. the molecular tumor board interprets the data and transforms them into treatment recommendations by identifying and prioritizing predictive biomarkers. the recommendations rely on the definition of evidence levels attributed to every single aberration and the interdisciplinary discussion of the aberrations with regard to patient situation, availability of drugs, and clinical trials. the recommendations are transmitted to the physician in charge of the patient for the final decision to treat or not the patient accordingly. the main endpoints are the number of patients with actionable molecular alterations, the number of patients with a treatment recommendation, the number of patients receiving the recommended therapy, overall survival of patients treated according to recommendations or not. for patients treated according to the recommendations: response rate and progression free survival at 6 months according to recist criteria.

Eligibility criteria:
inclusion criteria: * histologically proven metastatic melanoma failing standard treatments * age ≥ 18 years * eastern cooperative oncology group (ecog) performance status (ps) 0-2 * life expectancy ≥ 24 weeks * adequate renal, liver, and bone marrow functions exclusion criteria: - history of cardiac disease or metastatic brain or meningeal tumors
austrian randomized interventional study on dialysis accesses

Conditions: End Stage Renal Disease; Catheter Infection; Shunt Malfunction

Summary: patients with diagnosed end stage renal disease and indication for chronic dialysis rely on a well-functioning access for dialysis. the kdoqi guidelines for vascular access follows a "fistula first" approach for every patient, whenever possible. thus, every patient, regardless of age, clinical state and co-morbidities an arteriovenous fistula should be preferred over a tunneled cuffed catheter (tcc). these recommendations are based on retrospective and register studies. there have been no prospective studies in this subject so far. in addition, most of the collected data refers to patients of all ages, regardless of their comorbidities and general clinical state. in this study, we address differences between two dialysis vascular access types in elderly or frail patients. we will compare tccs with arteriovenous fistulas in the selected population consisting of elderly patients over 60 years of age or those with a charlson comorbidity index \>6 independent of age. in our hypothesis tccs will be superior to arteriovenous fistulas in this population regarding the examined end-points.


Eligibility criteria:
inclusion criteria: * age of 60 and higher * cci score \>6 when under 60 years * patients with ckd g5 a1-3 with indication for hemodialysis * stable clinical condition * eligibility for both arteriovenous fistula on the upper extremitiesandtcc * availability for follow-up. * written informed consent. exclusion criteria: * uncontrolled infection at screening and/or crp \>5 mg/dl (normal \<0.5 mg/dl) at screening. * poor general condition of health or malignancy not in remission at screening * major surgery within 12 weeks before screening. * pre-existent vascular access. * patient not eligible for any one of the vascular access options.
digital imaging aid for assessment of cervical dysplasia

Conditions: Cervical Dysplasia

Summary: the overall objective of this study is to evaluate whether polarized or green filtered digital imaging can assist clinicians to screen for premalignant lesions in the cervix. the specific aims of the study are: * to compare polarized and green filtered digital images of the cervix, to standard white light images, colposcopic evaluation and to pathologic analysis of biopsied tissue. * to develop algorithms to discriminate between normal and abnormal tissue based on digital images of the cervix. * to analyze digital images to determine which types of optical information yield the most diagnostically useful data.

if you agree to take part in this study, digital imaging will be performed for research purposes, after your routine colposcopy of your cervix. visual detection of precancerous lesions: reflectance (the ability of an area to reflect light) imaging helps doctors visually tell the difference between precancerous tissue, cancerous tissue, and normal tissue in the cervix. researchers want find out whether a digital camera image can be as effective as colposcopy at screening for precancerous tissue. study participation: you will be seen in the clinic during a routine visit. your cervix will first be examined by the clinician using a standard white light headlamp, and the image will be recorded. your cervix will then be re-examined with the digital camera, which will involve the use of different types of light (standard white light, green filtered light, cross and parallel polarized light). these digital images will be taken before and after acetic acid (vinegar) is applied. researchers will use these images to make comparison studies with the colposcopy procedure. length of study: your participation will be finished on this study once your cervix has been examined with the digital camera. this is an investigational study. up to patients 20 will take part in this study. all will be enrolled at m. d. anderson.

Eligibility criteria:
inclusion criteria: * patients 18 years or older who are referred to the university of texas md anderson cancer center colposcopy clinic for colposcopy are eligible for this study. * patients must sign an informed consent indicating awareness of the investigational nature of this study. exclusion criteria: * patients who are pregnant are not eligible for this study.

Keywords: cervical dysplasia digital imaging colposcopy cervix
the incidence and risk of vein infusion phlebitis after intravenous infusion of proton pump inhibitors

Conditions: Vein Infusion Phlebitis

Summary: intermittent or continuous proton pump inhibitor (ppi) therapy are recommended for high-risk bleeding ulcers according to the french society of gastroenterology. the prevalence of incidence of vein infusion phlebitis after ppi intravenous infusion is high in geriatric acute ward (about 10% of severe vein infusion phlebitis). the primary of objective of the study is to determinate the prevalence of vein infusion phlebitis after ppi intravenous infusion in aging people. the secondary of objective of the study if to determinate the factors of risk of vein infusion phlebitis.

this is a multicenter observational study. 5 centers will participate to the study. aging patients undergoing ppi intravenous infusion therapy will be proposed to be enrolled in the study. paramedical observation will be performed during 5 days for each enrolled patients.

Eligibility criteria:
inclusion criteria: * patients aged \> 70 years; * undergo intravenous continuous or intermittent proton pump inhibitor therapy; * patients being informed and not opposed to the study. exclusion criteria: * existing vein infusion phlebitis before the ppi infusion by intravenous route; * under guardianship or curators; * covered by french ame health system.

Keywords: vein infusion phlebitis proton pump inhibitor therapy intravenous infusion ulcer bleeding aging